United States - English - NLM (National Library of Medicine)

redpharm drug, inc. - oxycodone hydrochloride (unii: c1enj2te6c) (oxycodone - unii:cd35pmg570) - oxycodone hydrochloride 10 mg - oxycodone hcl extended-release tablets are indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate in: adults; and opioid-tolerant pediatric patients 11 years of age and older who are already receiving and tolerate a minimum daily opioid dose of at least 20 mg oxycodone orally or its equivalent. limitations of use because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations [see warnings and precautions (5.1)], reserve oxycodone hcl extended-release tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. oxycodone hcl extended-release tablets are not indicated as an as-needed (prn) a

United States - English - NLM (National Library of Medicine)

major pharmaceuticals - oxycodone hydrochloride (unii: c1enj2te6c) (oxycodone - unii:cd35pmg570), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - oxycodone hydrochloride 5 mg - oxycodone hydrochloride and acetaminophen tablets is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. limitations of use because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see warnings ], reserve oxycodone hydrochloride and acetaminophen tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics] oxycodone hydrochloride and acetaminophen tablets is contraindicated in patients with: oxycodone hydrochloride and acetaminophen tablets contain oxycodone, a schedule ii controlled substance. oxycodone hydrochloride and acetaminophen tablets contains oxycodone, a substance with a high potential for abuse similar to other opioids including fentanyl, hydrocodone, hydromorphone, methadone, morphine, oxymorphone, and tapentadol. oxycodone hydrochloride and acetaminophen tablets can be abused and is subject to misuse, addiction, and criminal diversion [s

United States - English - NLM (National Library of Medicine)

par pharmaceutical - oxycodone hydrochloride (unii: c1enj2te6c) (oxycodone - unii:cd35pmg570), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - oxycodone hydrochloride 5 mg - oxycodone hydrochloride and acetaminophen tablets is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. limitations of use because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see warnings ], reserve oxycodone hydrochloride and acetaminophen tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics] - have not been tolerated, or are not expected to be tolerated, - have not provided adequate analgesia, or are not expected to provide adequate analgesia oxycodone hydrochloride and acetaminophen tablets is contraindicated in patients with: - significant respiratory depression [see warnings ] - acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see warnings ] - known or suspected gastrointestinal obstruction, including paralytic ileus [see warnings ] - hypersensitivity to oxycodone, acetaminophen

United States - English - NLM (National Library of Medicine)

zydus pharmaceuticals (usa) inc. - oxycodone hydrochloride (unii: c1enj2te6c) (oxycodone - unii:cd35pmg570) - oxycodone hydrochloride 5 mg - oxycodone hydrochloride (hcl) tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. limitations of use because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see warnings and precautions (5.1)], reserve oxycodone hcl tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products): - have not been tolerated or are not expected to be tolerated, - have not provided adequate analgesia or are not expected to provide adequate analgesia. oxycodone hcl is contraindicated in patients with: - significant respiratory depression [see warnings and precautions (5.3)] - acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment or hypercarbia [see warnings and precautions (5.7)] - known or suspected gastrointestinal obstruction, including paralytic ileus [s

United States - English - NLM (National Library of Medicine)

ranbaxy pharmaceuticals inc. - oxycodone hydrochloride (unii: c1enj2te6c) (oxycodone - unii:cd35pmg570) - oxycodone hydrochloride 40 mg - oxycodone hcl extended-release tablets is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. limitations of use oxycodone hcl extended-release tablets is contraindicated in patients with: clinical considerations fetal/neonatal adverse reactions prolonged use of opioid analgesics during pregnancy for medical or nonmedical purposes can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth. observe newborns for symptoms of neonatal opioid withdrawal syndrome, such as poor feeding, diarrhea, irritability, tremor, rigidity, and seizures, and manage accordingly [see warnings and precautions (5.3)] . teratogenic effects - pregnancy category c there are no adequate and well-controlled studies in pregnant women. oxycodone hcl extended-release tablets should be used during pregnancy only if the potential benefit justifies the risk to the fetus.

Australia - English - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - oxycodone hydrochloride, quantity: 10 mg - tablet, modified release - excipient ingredients: macrogol 8000; ethylcellulose; titanium dioxide; hyprolose; hypromellose; colloidal anhydrous silica; lactose; magnesium stearate - apo-oxycodone mr modified release tablets are indicated for the management of severe pain where: ? other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain, and ? the pain is opioid-responsive; and ? requires daily, continuous, long-term treatment. apo-oxycodone mr is not indicated for the use in chronic non-cancer pain other than in exceptional circumstances. apo-oxycodone mr is not indicated as an as-needed (prn) analgesia.

Australia - English - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - oxycodone hydrochloride, quantity: 20 mg - tablet, modified release - excipient ingredients: iron oxide red; hyprolose; macrogol 8000; titanium dioxide; colloidal anhydrous silica; lactose; ethylcellulose; hypromellose; magnesium stearate - apo-oxycodone mr modified release tablets are indicated for the management of severe pain where: ? other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain, and ? the pain is opioid-responsive; and ? requires daily, continuous, long-term treatment. apo-oxycodone mr is not indicated for the use in chronic non-cancer pain other than in exceptional circumstances. apo-oxycodone mr is not indicated as an as-needed (prn) analgesia.

Australia - English - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - oxycodone hydrochloride, quantity: 15 mg - tablet, modified release - excipient ingredients: hypromellose; hyprolose; macrogol 8000; colloidal anhydrous silica; titanium dioxide; ferrosoferric oxide; lactose; iron oxide red; magnesium stearate; ethylcellulose - apo-oxycodone mr modified release tablets are indicated for the management of severe pain where: ? other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain, and ? the pain is opioid-responsive; and ? requires daily, continuous, long-term treatment. apo-oxycodone mr is not indicated for the use in chronic non-cancer pain other than in exceptional circumstances. apo-oxycodone mr is not indicated as an as-needed (prn) analgesia.

Australia - English - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - oxycodone hydrochloride, quantity: 30 mg - tablet, modified release - excipient ingredients: magnesium stearate; iron oxide yellow; hyprolose; hypromellose; iron oxide black; colloidal anhydrous silica; lactose; titanium dioxide; macrogol 8000; iron oxide red; ethylcellulose - apo-oxycodone mr modified release tablets are indicated for the management of severe pain where: ? other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain, and ? the pain is opioid-responsive; and ? requires daily, continuous, long-term treatment. apo-oxycodone mr is not indicated for the use in chronic non-cancer pain other than in exceptional circumstances. apo-oxycodone mr is not indicated as an as-needed (prn) analgesia.

Australia - English - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - oxycodone hydrochloride, quantity: 40 mg - tablet, modified release - excipient ingredients: titanium dioxide; hypromellose; ethylcellulose; iron oxide yellow; magnesium stearate; macrogol 8000; colloidal anhydrous silica; lactose; hyprolose - apo-oxycodone mr modified release tablets are indicated for the management of severe pain where: ? other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain, and ? the pain is opioid-responsive; and ? requires daily, continuous, long-term treatment. apo-oxycodone mr is not indicated for the use in chronic non-cancer pain other than in exceptional circumstances. apo-oxycodone mr is not indicated as an as-needed (prn) analgesia.